Phase 3 N=838 Randomized Treatment

Intravenous Thyroxine for Heart-Eligible Organ Donors

Brain Death · Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT04415658 ↗

Enrolled (actual)

838

Serious AEs

0.6%

Results posted

Jan 2024

Primary outcome: Primary: Heart Transplanted — 230; 223 Participants — p=0.57

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Thyroxine (Drug); Saline (Drug)
Age: Pediatric, Adult · 14+ yrs
Sex: All
Sponsor: Washington University School of Medicine
Primary completion: Nov 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Heart Transplanted	230; 223	0.57
PRIMARY Graft Function	224; 213	<0.001 sig
SECONDARY Time Till Off Vasopressors	22; 25	—
SECONDARY Weaned Off Vasopressors	143; 152	—
SECONDARY Time to Order Echo	12; 13	—
SECONDARY Ejection Fraction	59; 58	—
SECONDARY Lungs Transplanted	163; 149	—

Summary

This randomized controlled trial will evaluate whether intravenous thyroxine infusion given to brain-dead organ donors who are eligible to donate hearts for 12 hours will result in more hearts transplanted than saline placebo

Eligibility Criteria

Inclusion Criteria

Declared dead by neurologic criteria (brain dead)
Authorization for organ donation and research
On one or more vasopressors and/or inotropes

Exclusion Criteria

Brain death declared more than 24 hours prior
Only vasopressor is vasopressin
Weight < 45 kg (100 lbs)
Known coronary artery disease or history of myocardial infarction
Known valvular heart disease
Prior sternotomy or cardiac surgery
Donor at VA hospital
Received intravenous or oral thyroxine within past month
Known HIV+ status
Other reason donor is unable to receive study drug (determined by on-site personnel)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04415658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.